Sr. Quality Assurance Specialist

About the role

The Sr. Quality Assurance (QA) Specialist plays a critical role in ensuring compliance with regulatory requirements through the oversight of various Quality Systems. Key responsibilities include investigating deviations, managing customer complaints, maintaining Quality Risk Management, and supporting regulatory reporting.

Responsibilities

• Investigate and report issues under the deviation management system, including database management.
• Thoroughly investigate and implement corrective actions, focusing on root causes and avoiding reoccurrence.
• Work with departments to develop effective corrective and preventive actions, and follow up on their effectiveness.
• Investigate and report customer complaints, ensuring timely resolution and maintaining the customer complaint database.
• Maintain the Quality Risk Management system and provide support as needed.
• Support regulatory reporting and responses as required.
• Provide scientific and technical advice as needed.
• Participate in departmental and cross-functional meetings, and assist in project coordination.
• Generate thorough written reports summarizing investigations for out-of-specification results or out-of-procedure events.
• Support regulatory and internal inspections/audits, providing written responses as applicable.

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, Biochemistry or a closely related scientific/technical discipline.
• Minimum of 5 years of experience in a pharmaceutical, GMP, or FDA regulated environment.
• Direct experience in Quality Assurance, Quality Operations, Quality Control, or Quality Engineering.

Qualifications

• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Experience in conducting thorough investigations and root cause analysis.
• Strong technical writing skills.
• Demonstrated leadership skills and ability to motivate and train department personnel.
• Proactive, results-oriented approach with strong attention to detail.
• Excellent verbal and written communication skills.
• Computer literacy with proficiency in MS Office.

Skills

• In-depth understanding of pharmaceutical manufacturing, aseptic processing, and Quality Assurance/Operations.
• Knowledge of Quality systems and theory.
• Leadership and motivational skills.
• Problem-solving and decision-making abilities.
• Interpersonal and communication skills.
• Organizational and analytical skills.
• Self-starter with a strong work ethic.
• Ability to prioritize and manage multiple tasks.

Benefits

Final compensation packages will depend on education, experience, skillset, knowledge, location, internal equity, and market data. Additional benefits include medical, dental, vision, life insurance, PTO, paid holidays, and up to 5% 401(K) match and tuition reimbursement. Grifols is committed to professional growth and career progression, and offers a family-like culture with opportunities for employees to grow with the company.